WORLD TRADE  
ORGANIZATION   
G/TBT/N/CAN/337 
4 July 2011  
 (11-3261) 
Committee on Technical Barriers to Trade Original:   English/ 
 French 
 
 
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Notifying Member:  CANADA  
If applicable, name of local governme nt involved (Article 3.2 and 7.2):     
2. Agency responsible:  Department of Health 
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments regarding the notification shall be indicated if different from above :   
Canadian Enquiry Point  
200-270 Albert Street Ottawa, Ontario Canada, K1P 6N7  
Tel.:  +1 613 238 3222  
Fax:  +1 613 569 7808  E-mail:  enquirypoint@scc.ca  
3. Notified under Article 2.9.2 [ X ], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:   
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable):  Prescription status of 
medicinal ingredients for human use (ICS:  11.220) 
5. Title, number of pages and langua ge(s) of the notified document:  Proposed Amendment 
to the Food and Drug Regulations (Project No. 1659 - Schedule F) (5 pages in English; 
6 pages in French). 
6. Description of content:   
This notification announces the availability of a letter that provides an opportunity to 
comment on the proposed addition of six medicinal ingredients to Part I of Schedule F to the 
Food and Drug Regulations . 
Description of the medicinal ingredients: 1. The current listing for 'amiodarone and its salts' is revised to ' amiodarone, its salts and 
derivatives '. The revised listing is necessary to include the new medicinal ingredient, 
dronedarone, a derivative of amiodarone. Amioda rone, its salts and derivatives are used to 
treat irregular heartbeat.  Direct supervis ion by a practitioner with routine laboratory 
monitoring is required. There may be a narrow margin of safety between the therapeutic and 
toxic doses of amiodarone, its salts and derivatives. G/TBT/N/CAN/337 
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  2. Azacitidine, its salts and derivatives  are used to treat patients  with blood diseases related 
to abnormal production of blood cells in the bon e marrow but who are not  eligible for stem 
cell transplantation.  Individualized instruct ions, direct supervision by a practitioner and 
laboratory monitoring are required.   There may be a narrow ma rgin of safety between the 
therapeutic and toxic doses of azac itidine, its salts and derivatives. 
3. Certolizumab pegol  is a human monoclonal antibody used to treat active forms of 
rheumatoid arthritis, an inflam matory disorder that affects ti ssues and organs.  Individualized 
instructions or direct supervision by a pr actitioner and routine laboratory monitoring are 
required.  There may be a narrow margin of safe ty between the therapeutic and toxic doses of 
certolizumab pegol. 
4. The current listing for 'cladribine and its salts' is revised to ' cladribine, its salts and 
derivatives '.  The revised listing is necessary to  include the new medicinal ingredient, 
clofarabine, a derivative of cladribine. Cladribine, its salts and derivatives are used to treat 
leukemia. Individualized instru ctions, direct supervision by  a practitioner and laboratory 
monitoring are required.  There may be a narrow  margin of safety between the therapeutic 
and toxic doses of cladribine , its salts and derivatives. 
5. Degarelix, its salts and derivatives  are used to treat advanced prostate cancer by reducing 
levels of the hormone testosterone.  Individuali zed instructions or di rect supervision by a 
practitioner is required.  There are potential und esirable and severe side effects at normal 
therapeutic dosage levels of de garelix, its salts and derivatives. 
6. Urokinase  is an enzyme that is used  to treat patients with seve re blood clotting in the lungs 
(pulmonary emboli) or heart (c oronary artery thrombosis).  Individualized instructions or 
direct supervision by a practitioner is re quired along with monitoring against sudden and 
serious bleeding or infection.  There are pote ntial undesirable and seve re side effects at 
normal therapeutic dosage levels of urokinase. 
The degree of regulatory control afforded by Schedule F (prescription drug) status coincides 
with the risk factors associated with each medi cinal ingredient.  Oversight by a practitioner is 
necessary to ensure that appropriate risk/benef it information is considered before the drug 
containing the medicinal ingredient is administ ered and that the drug therapy is properly 
monitored. 
Schedule F is a list of medicinal ingredients, th e sale of which is controlled under sections 
C.01.041 to C.01.049 of the Food and Drug Regulations .  Part I of Schedule F lists 
ingredients that require a prescription for huma n use and for veterinary use.  Part II of 
Schedule F lists ingredients that  require a prescription for human use, but do not require a 
prescription for veterinary use if so labelled or if in a form unsuitable for human use. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health  
8. Relevant documents:   Therapeutic Products Dire ctorate (TPD) web site " http://www.hc-
sc.gc.ca/dhp-mps/prodph arma/legislation/noti ce-avis/index-eng.php ", Project No. 1659, 
letter posted: 22 June 2011   
9. Proposed date of adoption:   
  
Proposed date of entry into force:    Normally within 8 to 10 months from the 
posting of the letter on the TPD website On the date the measure is adopted  G/TBT/N/CAN/337 
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  10. Final date for comments:  5 September 2011 
11. Text available from:  National enquiry point [X], or address, telephone and fax 
numbers, e-mail and web-site addres ses, if available of the other body:    
The electronic version of Project No. 1659 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/consulta tion/drug-medic/project_projet_1659-eng.php  
(English)  
http://www.hc-sc.gc.ca/dhp-mps/consulta tion/drug-medic/proj ect_projet_1659-fra.php  
(French)